Original New Drug Application Approvals by US FDA (1-15 March 2024) | Multidisciplinary

New drug applications approved by US FDA as of 1-15 March 2024 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

CLOBETASOL PROPIONATE

Active Ingredient(s): Clobetasol Propionate
Strength: 0.05%
Dosage Form(s) / Route(s): Suspension/drops;ophthalmic
Company: Formosa Pharmaceuticals Inc
Approval Date: 04 March 2024
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated for the treatment of post-operative inflammation and pain following ocular surgery.
Approved Label: 04 March 2024 (PDF)

TYENNE

Active Ingredient(s): Tocilizumab-aazg
Strength: 162MG/0.9ML,80MG/4ML,200MG/10ML,400MG/20ML
Dosage Form(s) / Route(s): Injectable;subcutaneous,Injectable;intravenous
Company: Fresenius Kabi Usa
Approval Date: 05 March 2024
Submission Classification: Not Available
Indication(s): Indicated for treatment of:
- Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
- Adult patients with giant cell arteritis.
- Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
- Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
Approved Label: 05 March 2024 (PDF)

JUBBONTI

Active Ingredient(s): Denosumab-bbdz
Strength: 60MG/ML
Dosage Form(s) / Route(s): Injectable;subcutaneous
Company: Sandoz Inc
Approval Date: 05 March 2024
Submission Classification: Not Available
Indication(s): Indicated for:
- Treatment of postmenopausal women with osteoporosis at high risk for fracture.
- Treatment to increase bone mass in men with osteoporosis at high risk for fracture.
- Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture.
- Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.
- Treatment to increase bone mass in women at high risk for fracturereceiving adjuvant aromatase inhibitor therapy for breast cancer.
Approved Label: 05 March 2024 (PDF)

WYOST

Active Ingredient(s): Denosumab-bbdz
Strength: 120MG/1.7ML (70MG/ML)
Dosage Form(s) / Route(s): Injectable;subcutaneous
Company: Sandoz Inc
Approval Date: 05 March 2024
Submission Classification: Not Available
Indication(s):Indicated for:
- Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
- Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
- Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Approved Label: 05 March 2024 (PDF)

TALZENNA

Active Ingredient(s): Talazoparib
Strength: 0.1MG,0.25MG,0.35MG,0.5MG,0.75MG,1MG
Dosage Form(s) / Route(s): Capsule; Oral
Company: Pfizer Inc
Approval Date: 07 March 2024
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated for:
- As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.
- In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
Approved Label: 07 March 2024 (PDF)

TEVIMBRA

Active Ingredient(s):Tislelizumab
Strength:100MG/10ML
Dosage Form(s) / Route(s):Injection;solution
Company: Beigene
Approval Date: 13 March 2024
Submission Classification: Not Available
Indication(s): Indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
Approved Label: 13 March 2024 (PDF)

REZDIFFRA

Active Ingredient(s): Resmetirom
Strength:60MG, 80MG, 100MG
Dosage Form(s) / Route(s): Tablet;oral
Company: Madrigal Pharmaceuticals Inc
Approval Date: 14 March 2024
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). This indication is approved under accelerated approval based on improvement of NASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Limitations of Use
Avoid use of REZDIFFRA in patients with decompensated cirrhosis.
Approved Label: 14 March 2024 (PDF)

EDURANT

Active Ingredient(s): Rilpivirine
Strength: 25MG
Dosage Form(s) / Route(s): Tablet;oral
Company: Janssen Prods
Approval Date: 15 March 2024
Submission Classification: Type 3 - New Dosage Form
Indication(s): Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 2 years of age and older and weighing at least 14 kg with HIV-1 RNA less than or equal to 100,000 copies/mL.
Limitations of Use:
- More EDURANT treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to EDURANT treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL.
EDURANT is indicated in combination with VOCABRIA (cabotegravir), for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
Approved Label: 15 March 2024 (PDF)